SOFAMOR DANEK CORNERSTONE-SR Instrumentation Surgical Technique as described by: Kevin T. Foley, M.D. Semmes Murphey Clinic Stephen M. Papadopoulos, M.D. Ann Arbor, Michigan Regis W. Haid, Jr., M.D. Emory Clinic
Table of Contents Introduction...2 Patient Positioning & Incision...3 Exposure...4 Discectomy...6 Graft Site Preparation...8 Graft Site Preparation Free-Hand Technique...10 Graft Sizing...11 Graft Placement...13 Product Information...16 Important Information...19
Introduction Dear Fellow Colleagues, Anterior cervical discectomy utilizing the Smith-Robinson technique is a commonly performed procedure. The design goals of the CORNERSTONE-SR Instrumentation Set were to provide an expedient and reproducible means of preparing the cervical intervertebral space for receiving a Smith-Robinson-style graft. A series of cutters were designed to prepare parallel superior and inferior surfaces and create a posterior shelf in the endplates to prevent posterior migration of the graft after implantation. A corresponding set of graft sizing trials allows the surgeon to quickly and conveniently measure the prepared intervertebral space and choose the proper graft size for a precise fit. A graft holder, tamps, and mallet are included in the instrument set for graft positioning and impaction. Regeneration Technologies, Inc., of Alachua, Florida, offers pre-sized cortical allograft implants that can be used in conjunction with the CORNERSTONE-SR Instrumentation Set. The grafts are precisely machined to specific dimensions, maximizing the surface area of contact between the recipient vertebrae and the implant. * The advantages of this graft are its biomechanical strength, consistent bone quality, and the elimination of complications associated with autologous graft harvesting. The following monograph introduces the CORNERSTONE-SR Instrumentation Set, as well as many of our personal thoughts reflecting our current clinical practices and operative techniques. Sincerely, Kevin T. Foley, M.D. Semmes Murphey Clinic Memphis, TN Stephen M. Papadopoulos, M.D. Ann Arbor, MI Regis W. Haid, Jr., M.D. Emory Clinic Atlanta, GA * Each sizing trial in the CORNERSTONE-SR Instrumentation set is keyed to a corresponding graft size. 2
1 Patient Positioning & Incision The patient is placed in the supine position with the head in slight extension. The posterior cervical spine is supported to establish and maintain normal lordosis. The surgeon must then choose a right- or left-sided approach to the cervical vertebral column. After the approach is considered, the head may be rotated to allow for adequate exposure of the upper cervical spine (Figure 1). Typically a transverse skin incision is made. An avascular dissection plane is developed between the trachea and esophagus, medially, and the carotid sheath, laterally. Hand-held retractors are utilized to provide initial exposure of the anterior vertebral column and the adjacent longus colli muscles (Figure 2). I prefer the left-sided approach due to the anatomic reliability of the recurrent laryngeal nerve. I typically use a transverse skin incision with a vertical, muscle splitting incision of the platysma. Adequate longitudinal exposure of this level is critical, particularly in multilevel procedures. S. Papadopoulos, M.D. Figure 1 I typically approach from the right side and reserve the left-sided approach for redo surgery. K. Foley, M.D. Figure 2 3
2 Exposure After the anterior vertebral column has been exposed, the longus colli muscles are elevated and the medial/lateral self-retaining retractor blades are securely positioned beneath them (Figure 3a). The slotted blade may be used if an anterior osteophyte prevents proper positioning (Figure 3b). Then the longitudinal self-retaining retractor may be placed to provide optimal visualization (Figure 4). Figure 3a Figure 4 Figure 3b I usually perform an initial anterior discectomy widely to the uncovertebral joints, to allow proper anterior release prior to placement of the distraction pins. This is particularly important for the correction of cervical kyphosis. S. Papadopoulos, M.D. 4
2 Exposure A vertebral body distractor may be used. The distraction pins are positioned midline in the vertebral bodies adjacent to the discectomy (Figure 5). The distractor is placed over the pins and the appropriate amount of distraction is applied. Figure 5 I prefer to use halter traction to distract the interspace. This reduces the clutter in the wound. K. Foley, M.D. 5
3 Discectomy Discectomy is completed at the C5/C6 level. Pituitaries, curettes and kerrisons may be used to remove the disc material and cartilage to expose the posterior longitudinal ligament (Figures 6 and 7). Figure 7 Figure 6 6
3 Discectomy A high speed drill with a burr (match tip/round) may be utilized for removal of the posterior disc and osteophyte(s) to achieve neural decompression (Figures 8a and 8b). The posterior longitudinal ligament and osteophytes are then carefully removed. OFF 9LB Figure 8a Figure 8b 7
4A Graft Site Preparation Once the decompression is completed, endplate preparation is carried out. This consists of creating a precisely matched mortise with the bone graft using a CORNERSTONE-SR cutter. Select the CORNERSTONE-SR cutter that will decorticate the endplates with minimal bone removal, yet produce a posterior lip of bone to protect the spinal canal from posterior graft migration (Figure 9e). This cutter helps ensure parallel endplate preparation. The appropriate CORNERSTONE-SR cutter is determined by selecting the cutter whose distal tip just fits into the disc space (Figure 9a). The cutter length should match the A/P depth of the desired pre-machined allograft (provided by Regeneration Technologies, Inc.). The distal tip adds approximately 1.5mm to the overall length of the cutter. Figure 9a A Midas Rex drill may be utilized to create parallel endplates. R. Haid, M.D. 8
9LB CORNERSTONE-SR 4A Graft Site Preparation Generally, one pass of the cutter works best. Insert the cutter until the proximal cutter face aligns with the anterior cortex (Figure 9b). Starting on the contralateral side, pull the cutter medially. This affords better control and visualization of the distal tip in the disc space (Figures 9c and 9d). Proper use of the CORNERSTONE-SR cutter is what affords the reproducibility of the carpentry and thus will dictate the outcomes compared to a free-hand technique. S. Papadopoulos, M.D. Figure 9b OFF Figure 9d Figure 9e Figure 9c 9
4B Graft Site Preparation Free-hand Technique When using a free-hand technique, while maintaining normal lordosis, remove the anterior inferior edge of the superior vertebral bone (C5) and remove the posterior superior edge of the inferior vertebral bone (C6) (Figure 10a). This allows for better visualization and parallel endplates. Thus, in concept, there is both cortical bone for strength and to resist excessive subsidence and cancellous bone for bony ingrowth. R. Haid, M.D. Figure 10a When using a free-hand technique, I prefer to stay parallel to the endplates. This allows for better osteophyte removal at the uncovertebral joints, which are typically cephalad to the center of the disc space (Figures 10b and 10c). K. Foley, M.D. Figure 10b Figure 10c 10
5 Graft Sizing Graft sizing is determined by selecting the trial that provides the most satisfactory fit in the prepared disc space (Figure 11). If you have used a free-hand technique, the trials will allow you to gauge how parallel you have made your endplates. K. Foley, M.D. Figure 11 Tamp the trial completely into the interspace to ensure adequate fit of the graft. R. Haid, M.D. 11
5 Graft Sizing The trial should fit flush and produce a tight interference fit (Figures 12a and 12b). If it does not, choose a larger trial and/or re-evaluate your endplate preparation. This is the significant advantage to using a trial before selecting a final allograft size. K. Foley, M.D. Figure 12b If you choose a trial that is too large and over-force the trial, it may produce over distraction and cause the distraction pins to break out. R. Haid, M.D. Figure 12a 12
6 Graft Placement Select the CORNERSTONE-SR allograft size that corresponds to the final trial (Figures 13a and 13b). 5 5 6 6 6 5 5 6 6 6 7 7 7 7 7 7 7 7 7 10 8 8 8 8 8 8 8 8 10 10 9 9 9 9 9 9 11 11 12 13 Figure 13a Figure 13b Graft Holder/ Introducer 875-701 The superior and inferior surfaces of the CORNERSTONE-SR allograft have pre-machined grooves to help prevent anterior migration. S. Papadopoulos, M.D. I sometimes prefer to use the CORNERSTONE-SELECT allograft without grooves to increase graft-vertebral body interface. R. Haid, M.D. The graft is held in place with the graft holder. The graft is oriented with the curved surface positioned anteriorly (Figure 13c). The center of the implant can be left empty or packed with any osteoinductive material the surgeon desires (Figure 13d). Figure 13d I typically inject OSTEOFIL allograft paste (provided by Regeneration Technologies, Inc.) into the graft center. K. Foley, M.D. Figure 13c 13
6 The Graft Placement implant is introduced into the prepared graft site (Figures 13e and 13f) then tapped into place using a tamp and mallet (Figures 13g, 13h and 13i). If the surgeon so desires, an anterior cervical plate can then be applied (Figure 13j). Depending on the bone quality, I pre-load the graft by placing force on the intervertebral body pins. This allows for increased graft compression when the distraction pins are released. R. Haid, M.D. Figure 13f I place the shavings from the endplate preparation within the center of the implant. If this is not of sufficient quantity, then I augment this with OSTEOFIL allograft paste (provided by Regeneration Technologies, Inc.). S. Papadopoulos, M.D. Figure 13e 14
6 Graft Placement Figure 13h Figure 13i Figure 13j Figure 13g I add a hybrid ATLANTIS plate construct, with fixed rigid screws typically below and non-fixed variable screws above to allow controlled subsidence during graft loading. R. Haid, M.D. 15
CORNERSTONE-SR TRIALS INSTRUMENTS ITEM DESCRIPTION ITEM DESCRIPTION ITEM DESCRIPTION 874-511 5mm x 11mm x 11mm Trial 874-611 6mm x 11mm x 11mm Trial 874-711 7mm x 11mm x 11mm Trial 874-811 8mm x 11mm x 11mm Trial 874-911 9mm x 11mm x 11mm Trial 874-541 5mm x 14mm x 11mm Trial 874-641 6mm x 14mm x 11mm Trial 874-741 7mm x 14mm x 11mm Trial 874-841 8mm x 14mm x 11mm Trial 874-941 9mm x 14mm x 11mm Trial 874-041 10mm x 14mm x 11mm Trial 874-141 11mm x 14mm x 11mm Trial 874-241 12mm x 14mm x 11mm Trial 874-341 13mm x 14mm x 11mm Trial CORNERSTONE-SELECT TRIALS INSTRUMENTS ITEM DESCRIPTION ITEM DESCRIPTION ITEM DESCRIPTION 6820050 5mm Trial 6820060 6mm Trial 6820070 7mm Trial 6820080 8mm Trial 6820090 9mm Trial 6820100 10mm Trial 6820120 12mm Trial 6820130 13mm Trial 6820140 14mm Trial GENERAL INSTRUMENTS ( Shared) ITEM DESCRIPTION ITEM DESCRIPTION 875-701 Graft Holder/Introducer 875-7088mm Tapper 875-712 6 x 12mm Tapper 875-715 Mallet CASES ITEM DESCRIPTION ITEM DESCRIPTION 874990 Cornerstone-SR Case 8740995 Cornerstone-SELECT Case 16
CORNERSTONE-SR CUTTERS INSTRUMENTS ITEM SIZE ATTACHMENT ITEM SIZE ATTACHMENT 874-305 5mm Dia. 11mm Depth Mednext 9LB 874-306 6mm Dia. 11mm Depth Mednext 9LB 874-307 7mm Dia. 11mm Depth Mednext 9LB 874-3088mm Dia. 11mm Depth Mednext 9LB 874-309 9mm Dia. 11mm Depth Mednext 9LB 874-310 10mm Dia. 11mm Depth Mednext 9LB 874-315 5mm Dia. 14mm Depth Mednext 9LB 874-316 6mm Dia. 14mm Depth Mednext 9LB 874-317 7mm Dia. 14mm Depth Mednext 9LB 874-3188mm Dia. 14mm Depth Mednext 9LB 874-319 9mm Dia. 14mm Depth Mednext 9LB 874-320 10mm Dia. 14mm Depth Mednext 9LB 874-325 5mm Dia. 11mm Depth Mednext 12LB 874-326 6mm Dia. 11mm Depth Mednext 12LB 874-327 7mm Dia. 11mm Depth Mednext 12LB 874-3288mm Dia. 11mm Depth Mednext 12LB 874-329 9mm Dia. 11mm Depth Mednext 12LB 874-330 10mm Dia. 11mm Depth Mednext 12LB 874-335 5mm Dia. 14mm Depth Mednext 12LB 874-336 6mm Dia. 14mm Depth Mednext 12LB 874-337 7mm Dia. 14mm Depth Mednext 12LB 874-3388mm Dia. 14mm Depth Mednext 12LB 874-339 9mm Dia. 14mm Depth Mednext 12LB 874-340 10mm Dia. 14mm Depth Mednext 12LB 874-345 5mm Dia. 11mm Depth Stryker TPS 874-346 6mm Dia. 11mm Depth Stryker TPS 874-347 7mm Dia. 11mm Depth Stryker TPS 874-3488mm Dia. 11mm Depth Stryker TPS 874-349 9mm Dia. 11mm Depth Stryker TPS 874-350 10mm Dia. 11mm Depth Stryker TPS 874-385 5mm Dia. 11mm Depth Midas AM Attachment 874-386 6mm Dia. 11mm Depth Midas AM Attachment 874-387 7mm Dia. 11mm Depth Midas AM Attachment 874-388 8mm Dia. 11mm Depth Midas AM Attachment 874-389 9mm Dia. 11mm Depth Midas AM Attachment 874-390 10mm Dia. 11mm Depth Midas AM Attachment 874-391 5mm Dia. 11mm Depth Midas M Attachment 874-392 6mm Dia. 11mm Depth Midas M Attachment 874-393 7mm Dia. 11mm Depth Midas M Attachment 874-394 8mm Dia. 11mm Depth Midas M Attachment 874-395 9mm Dia. 11mm Depth Midas M Attachment 874-396 10mm Dia. 11mm Depth Midas M Attachment 874-405 5mm Dia. 11mm Depth Midas G8 Attachment 874-406 6mm Dia. 11mm Depth Midas G8 Attachment 874-407 7mm Dia. 11mm Depth Midas G8 Attachment 874-408 8mm Dia. 11mm Depth Midas G8 Attachment 874-409 9mm Dia. 11mm Depth Midas G8 Attachment 874-410 10mm Dia. 11mm Depth Midas G8 Attachment 17
TRIMLINE ACDF INSTRUMENT SET STANDARD DISTRACTOR SET ITEM DESCRIPTION ITEM DESCRIPTION 875-080 Vertebral Body Distractor (Right) 875-087 12mm Distractor Pins, (10/Pkg) Sterile 875-088 14mm Distractor Pins, (10/Pkg) Sterile 875-089 16mm Distractor Pins, (10/Pkg) Sterile 875-090 Distractor Screwdriver Note: Distractor pins are packaged sterile. STANDARD DISTRACTOR SET AUXILIARY ITEMS ITEM DESCRIPTION ITEM DESCRIPTION 875-084 Drill Guide (R) 875-950 Twist Drill KERRISONS ITEM DESCRIPTION ITEM DESCRIPTION ITEM DESCRIPTION 875-251 1mm Kerrison 875-252 2mm Kerrison 875-253 3mm Kerrison HAND-HELD RETRACTORS ITEM DESCRIPTION ITEM DESCRIPTION 875-050 Hand-Held Retractor, Straight, 18mm 875-051 Small Hand-Held Retractor, Straight, 18mm 875-052 Hand-Held Retractor, Back Lip, 20mm 875-053 Hand-Held Retractor, Curved, 23mm SELF-RETAINING RETRACTORS AND BLADES ITEM DESCRIPTION ITEM DESCRIPTION 875-110 Transverse Self-Retaining Retractor Frame 875-115 Longitudinal Self-Retaining Retractor Frame 875-149 Retractor Blade Handle 875-150 23x30mm Discectomy Blade 875-152 23x40mm Discectomy Blade 875-154 23x50mm Discectomy Blade 875-156 23x60mm Discectomy Blade 875-158 23x70mm Discectomy Blade 875-160 20x30mm Longitudinal Blade 875-162 20x40mm Longitudinal Blade 875-164 20x50mm Longitudinal Blade 875-166 20x60mm Longitudinal Blade 875-168 20x70mm Longitudinal Blade CURETTES ITEM DESCRIPTION ITEM DESCRIPTION ITEM DESCRIPTION 875-300 Curette Straight 6-0 875-302 Curette Straight 4-0 875-303 Curette Straight 3-0 875-304 Curette Straight 2-0 MICRO CURETTES 875-305 Curette Straight 1-0 875-307 Curette Straight 2-0 875-310 Curette Angled 6-0 875-312 Curette Angled 4-0 875-313 Curette Angled 3-0 875-314 Curette Angled 2-0 875-315 Curette Angled 1-0 ITEM DESCRIPTION ITEM DESCRIPTION ITEM DESCRIPTION 875-370 Micro Curette Straight 6-0 875-372 Micro Curette Straight 4-0 875-373 Micro Curette Straight 3-0 875-374 Micro Curette Straight 2-0 875-380 Micro Curette Angled 6-0 875-382 Micro Curette Angled 4-0 875-383 Micro Curette Angled 3-00 875-384 Micro Curette Angled 2-0 18
Important Information For Medtronic Sofamor Danek Instruments Purpose: This instrument is intended for use in surgical procedures. Description: Unless otherwise stated, instruments are made out of a variety of materials commonly used in orthopedic and neurological procedures including stainless steel and acetyl copolymer materials which meet available national or international standards specifications as applied to these devices. Some instruments are made in aluminium, and some with handles made of resin bonded composites, and while these can be steam autoclaved, certain cleaning fluids must not be employed. None of the instruments should be implanted. Intended Use: This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used. If there is any doubt or uncertainty concerning the proper use of this instrument, please contact MEDTRONIC SOFAMOR DANEK Customer Service for instructions. Any available surgical techniques will be provided at no charge. Warnings: The methods of use of instruments are to be determined by the user's experience and training in surgical procedures. Do not use this instrument for any action for which it was not intended such as hammering, prying, or lifting. This instrument should be treated as any precision instrument and should be carefully placed on trays, cleaned after each use, and stored in a dry environment. To avoid injury, the instrument should be carefully examined prior to use for functionality or damage. A damaged instrument should not be used. Additional back-up instruments should be available in case of an unexpected need. MEDTRONIC SOFAMOR DANEK does not and cannot warrant the use of this instrument nor any of the component parts upon which repairs have been made or attempted except as performed by MEDTRONIC SOFAMOR DANEK or an authorized MEDTRONIC SOFAMOR DANEK repair representative. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Possible Adverse Effects: Breakage, slippage, misuse, or mishandling of instruments, such as on sharp edges, may cause injury to the patient or operative personnel. Improper maintenance, handling, or poor cleaning procedures can render the instrument unsuitable for its intended purpose, or even dangerous to the patient or surgical staff. Proper patient selection and operative care are critical to the success of the device and avoidance of injury during surgery. Read and follow all other product information supplied by the manufacturer of the implants or the instruments. Special precautions are needed during pediatric use. Care should be taken when using instruments in pediatric patients, since these patients can be more susceptible to the stresses involved in their use. There are particular risks involved in the use of instruments used for bending and cutting rods. The use of these types of instruments can cause injury to the patient by virtue of the extremely high forces which are involved. Do not cut rods in situ. In addition, any breakage of an instrument or the implant in this situation could be extremely hazardous. The physical characteristics required for many instruments does not permit them to be manufactured from implantable materials, and if any broken fragments of instruments remain in the body of a patient, they could cause allergic or infectious consequences. Over-bending, notching, striking and scratching of the implants with any instrument should be avoided to reduce the risk of breakage. Under no circumstances should rods or plates be sharply or reverse bent, since this would reduce the fatigue life of the rod and increase the risk of breakage. When the configuration of the bone cannot be fitted with an available device and contouring of the device is absolutely necessary, contouring should be performed only with proper bending equipment, and should be performed gradually and with great care to avoid notching or scratching the device. Extreme care should be taken to ensure that this instrument remains in good working order. Any surgical techniques applicable for use of this system should be carefully followed. During the procedure, successful utilization of this instrument is extremely important. Unless labeled for single use, this instrument may be reused. This instrument should not be bent or damaged in any way. Misuse of this instrument, causing corrosion "freezing-up", scratching, loosening, bending and/or fracture of any or all sections of the instrument may inhibit or prevent proper function. It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves or vessels, and that the forces applied while correcting the position of the instrumentation is not excessive, such that it might cause injury to the patient. Excessive force applied by instruments to implants can dislodge devices, particularly hooks. Never expose instruments to temperatures in excess of 134 C that may considerably modify the physical characteristics of the instruments. CAUTION : FOR USE ON OR BY THE ORDER OF A PHYSICIAN ONLY. CAUTION: FEDERAL (U.S.) LAW RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN ONLY. This device should be used only by physicians familiar with the device, its intended use, any additional instrumentation and any available surgical techniques. For the best results MEDTRONIC SOFAMOR DANEK implants should only be implanted with MEDTRONIC SOFAMOR DANEK instruments. Other complications may include, but are not limited to : 1. Nerve damage, paralysis, pain, or damage to soft tissue, visceral organs or joints. 2. Breakage of the device, which could make necessary removal difficult or sometimes impossible, with possible consequences of late infection and migration. 3. Infection, if instruments are not properly cleaned and sterilized. 4. Pain, discomfort, or abnormal sensations resulting from the presence of the device. 5. Nerve damage due to surgical trauma. 6. Dural leak in cases of excessive load application. 7. Impingement of close vessels, nerves and organs by slippage or misplacement of the instrument. 8. Damage due to spontaneous release of clamping devices or spring mechanisms of certain instruments. 9. Cutting of skin or gloves of operating staff. 10. Bony fracture, in cases of deformed spine or weak bone. 11. Tissue damage to the patient, physical injury to operating staff and/or increased operating time that may result from the disassembly of multi-component instruments occurring during surgery. Other Precautions: 1. Excessive forces when using bending or fixation instruments can be dangerous especially where bone friability is encountered during the operation. 2. Any form of distortion or excessive wear on instruments may cause a malfunction likely to lead to serious patient injury. 3. Regularly review the operational state of all instruments and if necessary make use of repair and replacement services. Device Fixation: Some surgeries require the use of instruments which incorporate a measuring function. Ensure that these are not worn, that any surface engravings are clearly visible. Where there is a need for a specified tightening torque, this may normally be achieved with torque setting instruments supplied by MEDTRONIC SOFAMOR DANEK; the pointer on these instruments must indicate ZERO before use. If not, return for recalibration. With small instruments, excess force, beyond the design strength of the instrument, can be caused even by simple manual overloading. Do not exceed recommended parameters. To determine the screw diameter with the screw gauge, start with the smallest test hole. Packaging: MEDTRONIC SOFAMOR DANEK instruments may be supplied as either sterile or non- sterile. Sterile instruments will be clearly labeled as such on the package label. The sterility of instruments supplied sterile can only be assured if the packaging is intact. Packages for both sterile and non-sterile components should be intact upon receipt. All sets should be carefully checked for completeness and all components should be carefully checked for signs of damage, prior to use. Damaged packages or products should not be used and should be returned to MEDTRONIC SOFAMOR DANEK. Remove all packaging material prior to sterilization. Only sterile implants and instruments should be used in surgery. Always immediately resterilize all instruments used in surgery. Instruments should be thoroughly cleaned prior to re-sterilization. This process must be performed before handling, or before returning product to MEDTRONIC SOFAMOR DANEK. 19 Decontamination and Cleaning: All instruments should be thoroughly cleaned before sterilization using established hospital methods. This includes the use of neutral cleaners followed by deionized water rinse. Note: Certain cleaning solutions such as those containing caustic soda, formalin, glutaraldehyde, bleach and/or other alkaline cleaners may damage some devices, particularly instruments; these solutions should not be used. Also, certain instruments may require dismantling before cleaning. All instruments should be treated with care. Improper use or handling may lead to damage and possible improper functioning of the instrument. Examination: Instruments must always be examined by the user prior to use in surgery. Examination should be thorough, and in particular, should take into account a visual and functional inspection of the working surfaces, pivots, racks, spring or torsional operation, cleanliness of location holes or cannulations, and the presence of any cracks, bending, bruising or distortion, and that all components of the instrument are complete. Never use instruments with obvious signs of excessive wear, damage, or that are incomplete or otherwise unfunctional. Sterilization: Unless supplied sterile and clearly labeled as such, this instrument must be sterilized before use. MEDTRONIC SOFAMOR DANEK instruments for use with internal spinal fixation implants must be steam sterilized according to the following process parameters : METHOD: Steam CYCLE:Gravity TEMPERATURE: 121 C (250 F) EXPOSURE TIME: 30 min. Or : METHOD: Steam CYCLE:Pre-Vacuum TEMPERATURE: 132 C (270 F) EXPOSURE TIME: 4 min. For use of this product and instruments outside the United States, some non-u.s. Health Care Authorities recommend sterilization according to these parameters so as to minimize the potential risk of transmission of Creutzfeldt-Jakob disease, especially of surgical instruments that could come onto contact with the central nervous system : METHOD: Steam CYCLE: Gravity TEMPERATURE: 134 C (273 F) EXPOSURE TIME: 18 min. Operative Use: The physician should take precautions against putting undue stress on the spinal area with instruments. Any surgical technique instruction manual should be carefully followed. Removal of Implants: For the best results, the same type of MEDTRONIC SOFAMOR DANEK instruments as used for implantation should be used for implant removal purposes. Various sizes of screwdrivers are available to adapt to the removal drive sizes in auto break fixation screws. It should be noted that where excessive bone growth has occurred, there may be added stress on the removal instruments and the implants. Both instrument and implant may be prone to possible breakage. In this case it is necessary to first remove the bone and/or tissue from around the implants. Further Information: In case of complaint, or for supplementary information, please see the address page of this information sheet. Product Complaint: Any Health Care Professionals (e.g., customer users of MEDTRONIC SOFAMOR DANEK instruments), who have any complaint or who have experienced dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness and/or performance, should notify the distributor, MEDTRONIC SOFAMOR DANEK. Further, if any instrument malfunctions, (i.e., does not meet any of its performance specifications or otherwise does not perform as intended), or is suspected of doing so, the distributor or MEDTRONIC SOFAMOR DANEK should be notified immediately. If any MEDTRONIC SOFAMOR DANEK product ever malfunctions and may have caused or contributed to the death or serious injury of a patient, the distributor or MEDTRONIC SOFAMOR DANEK should be notified as soon as possible by telephone, FAX or written correspondence. When filing a complaint, please provide the component(s) name and number, lot number(s), your name and address, and the nature of the complaint. 2000 MEDTRONIC SOFAMOR DANEK, Inc. All rights reserved.
Notes 20
For product availability, labeling limitations, and/or more information on any Medtronic Sofamor Danek products, contact your MEDTRONIC SOFAMOR DANEK USA Sales Associate, or call MEDTRONIC SOFAMOR DANEK USA Customer Service toll free: 800-933-2635. SOFAMOR DANEK MEDTRONIC SOFAMOR DANEK USA 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133 Fax: (901) 332-3920 Wats: (800) 876-3133 Customer Service: (800) 933-2635 www.sofamordanek.com See package insert for labeling limitations. 2000 Medtronic Sofamor Danek. All Rights Reserved. Patents Pending. LIT.CSR.ST00